The post holder will join a multi-discipline team tasked with the development and manufacture of novel cell and gene therapy products. The Quality Lead will initially focus in early procedural and protocol development in preparation and implementation for a newly build GMP manufacturing facility for Cell and Gene Therapy and other ATMPs. The Quality Lead will form part of a new expanding team that will implement Esco Aster’s manufacturing and product pipeline agenda for its new facility and will play a key role in the start-up of the new facility and it’s processes and will subsequently drive manufacturing development. The candidate will be reporting to the Chief Executive Officer and will work closely with both the R&D department as well build out the Quality Department to ensure translational development of product candidates is conducted to regulatory compliance in the rapidly evolving field of cell and gene therapy for clinical applications. This is a unique opportunity. The Quality Lead will also be expected to, assist quality investigation and process deviations, and support internal and external inspections. In addition, the Quality Lead is expected to actively contributing to maintain Good Manufacturing Practice (GMP) compliance and to a Healthy and Safe Working Environment.
- Drive protocol and procedural development during the early phase of the facility build.
- Act as the key point of contact during the start-up activities of the facility and its processes such as: assisting with C&Q activities, establishing manufacturing SOPs, and establishing training programmes.
- Lead initial process introduction trials.
- Implement SOP activities.
- Support translation of developed / optimised process into full-fledged manufacturing cellular processes.
- Support manufacturing team to coordinate manufacturing runs.
- Act as the key point of contact for internal and external inspections.
- Be a role model for Quality and Production
- Instigate, drive and actively encourage continuous improvement initiatives.
- BSc / MSc / PhD in Cell and Molecular Biology and / or biological sciences.
- Proficient in carrying out GMP manufacturing processes preferably in cell therapy.
- Knowledge and track record in QC assay validation essential.
- Knowledge in regulatory requirement in Manufacturing Quality Assurance highly desirable (e.g. FDA, EMA).
- Experience in relevant regulatory agencies is preferred.
- Pharmaceutical industry experience desirable.
- Previous experience in leading manufacturing operations and staff supervision desirable
- Technical track record in mammalian cell culture and other cellular and molecular biology methodologies
- Self-motivated driven individual and goal oriented
- Well versed in meeting deliverables and timelines
- Ability to think laterally with good problem solving skills through evidence based approaches
- Detail and task oriented, flexible and ability to work in a rapid changing environment
- Ability to carry out tasks both independently or as part of team oriented exercise
- Good interpersonal, mentoring and communication skills with willingness to challenge ideas
- Enthusiastic, positive and resilient